Alcon 23G and 25G Valved Entry System provides access into the… — Class II medical device recall Z-1692-2016
Terminated recall by Alcon Research, Ltd., reported 2016-05-25, distributed in PR. The product has potential to leak beyond their design specification.
| Recall number | Z-1692-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, Ltd., Fort Worth, TX, United States |
| Recall initiated | 2015-08-11 |
| Classified | 2016-05-18 |
| Reported by FDA | 2016-05-25 |
| Terminated | 2017-04-20 |
| Distributed | PR |
| Countries outside the US | AE, AR, AU, BD, BE, BG, BR, CA, CH, CL, CN, CO, CW, DE, DK, EC, ES, FI, GB, GR, HK, HU, IE, IN, IS, IT, JP, KR, LT, MT, MX, NL, NZ, PH, PL, RO, RU, SE, SG, SK, TH, TR, TT, TW, UA, UY, ZA |
| Quantity | 83,448 units |
| Reason classes | packaging |
| Lot numbers | 15011624X, 15013312X, 15013313X, 15014272X, 15014273X, 15015769X, 15016782X, 15016783X, 15016784X, 15018549X, 15018550X, 15018554X, 15018602X, 15018603X, 15018606X, 15018888X, 15018890X, 15020828X, 15020830X, 15021333X, 15021337X, 15022350X, 15022414X, 15022416X, 15025385X, 15025395X, 15027298X, 15027819X, 15027820X, 15027834X, 15027843X, 15028267X, 15028268X, 15031226X, 15031229X, 15031231X, 15031232X, 15032112X, 15034244X, 15034779X |
Product
Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
Reason for recall
The product has potential to leak beyond their design specification.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1692-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.